Simon Scholes from First Berlin asked a direct question about the company's financial forecast, inquiring whether the projected operating expenses for the year include any milestone payments related to leniolumab (Joenja).
CEO Fabrice Chouraqui provided a clear and concise answer, confirming that the full-year operating expense forecast does include a $5 million milestone payment.
Simon Scholes from First Berlin Equity Research GmbH asked for specific details on which areas of General & Administrative expenses would be targeted to achieve the planned $10 million annual cost reduction, noting the challenge of doing so amid strong revenue growth.
CEO Fabrice Chouraqui acknowledged the plan is ambitious but stated he could not share specific details at this time. He reiterated that the goal is to enhance financial discipline and optimize capital allocation to drive both top-line and bottom-line growth, thereby maximizing value creation. He promised to share more details when the plan is finalized.
Simon Scholes from First Berlin Equity Research followed up on the Abliva acquisition costs, asking how they might evolve in 2026-2027. He also asked for clarification on the clinical trial pathway for CVID, questioning if a Phase III trial would be required and if it could receive Fast Track designation.
CEO Fabrice Chouraqui reiterated the total Abliva program cost estimate of $120-$125 million, with costs beyond 2025 falling within that budget. CMO Anurag Relan clarified that a Phase III study is indeed anticipated for CVID, similar to other rare disease programs, and confirmed they will explore all expedited development options like Fast Track designation.
Simon Scholes asked about the expected timeline for leniolisib's second indication following the Phase II data readout and requested more precise timing for approvals in Canada and Australia, which are now expected in 2025.
CEO Sijmen de Vries clarified that the Phase II data for the second indication is more likely expected by the end of 2025, not early next year. Regarding Canada and Australia, he confirmed the company anticipates regulatory action in 2025 but declined to provide more detailed timelines, citing the unpredictable nature of regulatory interactions.
Simon Scholes from First Berlin inquired about idle capacity costs and efforts to reduce them, the sustainability of the high Q1 gross margin for IXIARO, and whether the DUKORAL gross margin could approach 60% over time.
CFO Peter Buhler reported idle costs were approximately €2 million in Q1, which are expected to decrease as production transfers to the new Scotland facility. He indicated the high Q1 IXIARO margin of 73% is likely not representative for the full year, though improvement is expected. He suggested the Q1 DUKORAL gross margin is roughly representative of future expectations.